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NCT02329366 Clinical Trial

Development of a Cellular Biomarker for the Diagnosis and Treatment of Diabetic Foot Ulcers

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02329366
Other study ID # 14328
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2014
Est. completion date December 1, 2020

Study information
Verified date April 2023
Source Winthrop University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This project aims to result in the identification of such markers, and the development of a feasible quantitative method of distinguishing between tissue that has the capacity to heal and tissue that does not, thus identifying a non-healing phenotype.

Description:

The goal of this project is to identify objective, quantitative biological and molecular markers that correlate with healing outcomes for diabetic foot ulcers (DFUs) using debrided tissue of patients with wounds. This project aims to result in the identification of such markers, and the development of a feasible quantitative method of distinguishing between tissue that has the capacity to heal and tissue that does not, thus identifying a non-healing phenotype. The ability to differentiate between healing and non-healing tissue at the onset of wound care will allow for the use of targeted therapies and earlier initiation of aggressive treatments where indicated.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 1, 2020
Est. primary completion date December 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female, age = 18 - Type 2 Diabetes - A break in the skin on the foot = 0.5cm2 and is Grade 1 or 2 as defined by the Wagner grading system - Hemoglobin A1c = 5.9% - Ability to provide written informed consent Exclusion Criteria: - Any experimental drugs taken orally or topically within 4 weeks of study entry - Malignant disease at/or in proximity to the DFU - Target wound of malignant origin - Failure to satisfy at least one inclusion criterion for one of the two study groups.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Specimen Collection
. In this study, diabetic patients undergoing DFU debridement under the standard of care will be asked for their permission to collect the debrided tissue for use in scientific research.

Locations
Country Name City State
United States Winthrop University Hospital Mineola New York

Sponsors (1)
Lead Sponsor Collaborator
Winthrop University Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To identify objective, quantitative biological and molecular markers that correlate with healing outcomes for diabetic foot ulcers (DFUs) using debrided tissue of patients with wounds Undetermined
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